Pettit, L., Sanghera, P., Glaholm, J., & Hartley, A. (2014). The use of MuGard™, Caphosol® and Episil® in patients undergoing chemoradiotherapy for squamous cell carcinoma of the head and neck. Journal of Radiotherapy in Practice, 13(2), 218–225.

DOI Link

Study Purpose

To record mucositis and dysphagia toxicity and level of anesthesia for patients receiving MuGard, Caphosol, or Episil in comparison to standard care

Intervention Characteristics/Basic Study Process

Patients undergoing concurrent radiotherapy and chemotherapy for locally advanced head and neck cancer were audited for eight weeks during treatment. Patients were sequentially given either the standard oral care regimen of aspirin, glycerin, and sucralfate and Gelclair® or one of the other products. Patients were assessed weekly during four weeks of radiotherapy and for four weeks after completion. All patients received the same protocol approach for analgesia.

Sample Characteristics

  • N = 104  
  • AGE: Not reported
  • MALES: Not reported, FEMALES: Not reported
  • KEY DISEASE CHARACTERISTICS: All had squamous cell head and neck cancer, most were of the oropharynx. All were receiving concurrent carboplatin or cetuximab. Radiotherapy was 55 Gy in 20 fractions over 25 days.

Setting

  • SITE: Single site 
  • SETTING TYPE: Outpatient 
  • LOCATION: United Kingdom

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Observational

Measurement Instruments/Methods

Common Terminology Criteria for Adverse Events v3

Results

No differences were seen between groups in average grade of dysphagia or analgesia use. No differences were seen between those receiving radiotherapy with intensity-modulated radiation therapy or conformal radiotherapy.

Limitations

  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Unintended interventions or applicable interventions not described that would influence results
  • A much larger group of patients was in the standard care group. No information is provided about general oral care, and frequency of use of any of the oral agents is not described. Adherence varied considerably across groups, with the largest adherence to the standard care regimen.

Nursing Implications

This study had numerous design limitations and provides little supportive evidence for any of the approaches used for prevention and management of oral mucositis or associated pain.